This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Cardiac ejection fraction (EF) is a good index of left ventricular dysfunction and low EF (less than 30%) is a risk for stroke in patients with cardiac failure. This study is a 2 arm, 1:1 double blind randomized multicenter clinical trial (target enrollment 2860 patients at 70 clinical sites) designed to test the primary null hypothesis of no difference between warfarin (INR 2.5-3.0) and aspirin (325 mg) in 3-5 year survival for the composite endpoint of death or recurrent stroke or intracerebral hemorrhage among patients with low EF. Secondary hypotheses are to be tested for subgroups of women and African Americans, and for the endpoint of stroke alone. Patients with low EF by quantitative assessment or with a wall motion index less than 1 by echocardiography will be randomized to warfarin or aspirin. The dose of warfarin will be adjusted to keep the INR between 2.5 to 3.0 with a target INR of 2.75, using a double-blind algorithm to fabricate INRs for patients on active aspirin. Patients will be contacted monthly by phone and examined every four months over a mean follow-up of 3 years to determine whether any endpoints have occurred. The study will define optimal antithrombotic therapy for patients with cardiac failure and patients with low EF.
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